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IMPACT OF CLINICAL RESEARCH ON THE SOCIETY

Support of innovation in the field of pharmaceuticals is one of the most salient value propositions made by AIFD to the Turkish society and economy. When we analyse pharmaceutical R&D investments that forms the most important element of the value chain, we realise that out of the global R&D investments amounting to 180 billion US dollars, 61% are allocated to the clinical trials.

It is plausible to obtain stunning results in clinical trials within the short term span of 3 to 5 years and to bring Turkey rapidly to higher echelons in the international competition. There is an intense competition among countries to get a larger share from the global clinical trials market worth USD 110 billion annually. Therefore, in the pharmaceutical value chain it is proposed to strategically focus as a first step on clinical trials, in order to create with the shared wisdom of the private and public sectors a model that would create a leap forward similar to South Korea’s advance in the last 10 years.

Based on this opportunity and need, AIFD finalized a very important report project in 2019. The survey conducted by IQVIA, a reputable international consulting firm, under the coordination of AIFD and with the contribution of EFPIA, delivered a report highlighting 'the importance and contribution of clinical trials conducted in Turkey’, comparing the data with the world data. In the study, three main benefits of clinical trials in terms of economic, scientific progress and early access of patients to innovative treatment were examined. As a result of a participatory process including a large multi-stakeholder workshop, 12 development areas were identified in the report.

The launch of the report planned for March 2020 was delayed due to the Covid-19 pandemic. "Benefits of a Clinical Research Strategy for Turkey – a Roadmap for Innovation-driven Growth" report was shared with the public during the TUSEB Biotechnology Symposium on September 17, 2020. Keynote speeches during the launch of the report were delivered by Prof. Dr. Emine Alp Meşe, Deputy Minister of Health; Assoc. Prof. Tolga Tolunay, Director of the Turkish Pharmaceuticals and Medical Devices Agency (TİTCK); Dr. Mete Hüsemoğlu, Chairperson of the AIFD Board of Directors and Ms. Nathalie Moll, Director General of EFPIA.




Following the presentation of the report by Ms. Şule Sencer Akbil, IQVIA Engagement Manager, a panel titled, "Importance of Clinical Trials for Turkey and What Kind of a Joint Working Model is Needed to Implement a Roadmap?” was organised. Prof. Dr. Ahmet Gül from Istanbul Univ. Medical School was the moderator of the panel where Ms. Nihan Burul Bozkurt, TITCK Clinical Trials Department Head; Mr. Kutluhan Taşkın, from Presidency of the Republic of Turkey, Directorate of Strategy and Budget, General Manager of Plans & Programs; Dr. Hasan Arslan, Deputy General Manager of Public Hospitals, Ministry of Health; Prof. Dr. İlhan Satman, Board Member of the Turkey Institutes of Health and Mr. Özgür Ertok, Country Manager of IQVIA Consulting took part as panelists.


Mr. Özgür Ertok, Country Manager of IQVIA Consulting, stated that "We observe that currently 139 million US dollars worth of foreign investment is chanelled to Turkey for clinical trials and contributes directly to the macroeconomic balance which is one the major objectives of the New Economic Plan. Considering the size of the world market and the potential of Turkey in conducting clinical trials, we realise that planning and the creation of an ecosystem are necessary to raise this investment in the first phase to USD 500 million and in the second phase to USD 1 billion.”

During the online press conference held after the launch, AIFD Chairperson Dr. Mete Hüsemoğlu made the following statement: “As research-based pharmaceutical companies, our main mission is to work with all our stakeholders to ensure the access of patients in Turkey to the latest treatments. Clinical research, which enables us to understand the effect and safety of newly developed medicines and treatments on humans, is vital for human health. Our country has a significant clinical research capacity. One of the main findings of our report, which we are happy to share with the public, is that clinical research generates high added value in the fields of economy, health and science. Policies that we can implement with public-private sector cooperation can make our country one of the most important actors in the world in clinical research, as well as establish an ecosystem that feeds other valuable links of the pharmaceutical value chain such as basic research, production and export. We believe that our report will be an important roadmap for all stakeholders towards this process." Main messages from the “Benefits of a clinical research strategy for Turkey – A roadmap for innovation driven growth” Report
“Clinical trials, which are defined as scientific studies conducted with the participation of volunteers and aiming to obtain medical information, are among the most important processes that ensure the effectiveness and safety of newly released medicines for human use. The report aimed to investigate the value of clinical research in Turkey and to define the conditions necessary to increase investments in clinical research in Turkey in the medium term; it is based on a survey conducted with the participation of 17 AIFD member companies and covers the pharmaceutical sector in Turkey, the trends in global R&D investments and clinical research, it provides important data and insights on the role of clinical trials in Turkey on the economic, scientific and public health dimensions, as well.

The report highlights the following findings:

  • Turkey is ranked 17th in world pharmaceutical market , while it is ranked 26th in the number of worldwide conducted clinical trials.
  • The annual contribution of clinical studies conducted in Turkey, which are the total of direct investments in clinical studies and the value of the economic contribution of the innovative drugs used in clinical trials, is calculated as USD 327.7 million as of as June 2019.
  • Clinical studies provide direct contributions to the Turkish economy, health services and to patients.
  • Turkey can provide improvement in the main factors that increase the attraction of clinical research.
  • Turkey should triple the number of clinical studies in the country to be placed in the top 10 countries conducting clinical research.

Well over 21 thousand patients are treated in clinical trials in Turkey.

  • Clinical trials create better health outcomes with their contribution to the quality of life of the patients. Patients participating in clinical trials can benefit from the highest quality of service and the most advanced, even life-saving treatment methods.
  • Studies show that clinical trials produce more positive outcomes for patients involved, regardless of whether they are in the placebo or active substance group.
  • Thanks to clinical trials, patients also have early access to innovative drugs, medical devices and treatments that can be used in the future.
  • Currently 21,700 patients get treatment opportunities in industry-sponsored clinical trials currently ongoing across Turkey. It is expected that the number of clinical trials currently numbering 521, would triple in eight years after the report recommendations are put into practice.

Clinical trials reduced the financial drug burden on SSI (SGK) by USD 41.8 million.

  • The total annual economic value of clinical studies in Turkey, as of June 2019 is estimated to topple USD 327.7 million (1860.1 million TL).
  • USD 139.0 million ( 788.8 million TL ) worth of clinical research investment in Turkey in 2019, corresponded to 1.8% of Turkey's total size of the pharmaceutical industry (a decline from 2.7% level in 2015) and was equivalent to the 0.02% of the GDP in Turkey.
  • During the last 10 years the number of active clinical studies in Turkey showed a compounded growth rate of 3.6%.
  • The reduced financial drug burden on SSI, thanks to clinical research, corresponds to a total of USD 41.8 millions (237.3 million TL). Thanks to ongoing clinical studies, this total financial burden on the SSI is reduced every year.
  • Additional income for healthcare institutions from these clinical research resources amounted to USD 23.4 million (133.0 million TL) annually. The total estimated value of employment created through clinical research is estimated to be USD 44.4 million (251.8 million TL) annually.
  • In case the "rapid growth" scenario is implemented, Turkey is expected to be among the top 10 countries in terms of the total number of clinical trials in 2027 and among the 6th-7th countries in the number of new clinical trials (among USA, United Kingdom, Spain, Germany, Canada, France and Italy) .
  • As a large proportion of the industry-supported clinical research in Turkey is carried out by multinational pharmaceutical companies, a substantial portion of the investment in clinical research is assessed as foreign direct investment. In this respect, clinical research investments directly contribute to maintaining the macroeconomic balance and improving the current account balance, which are among the main objectives of the New Economic Program.

Clinical research provides the transfer of global knowledge to Turkey.

  • Clinical research is increasing scientific development in Turkey, is expanding scientific acquisitions and accelerating the transfer of global know-how and knowledge to Turkey.
  • Turkish academicians participating in clinical research are not only increasing their know-how and gaining early experience about new treatments, they also receive up-to-date training on drug development processes and new treatment areas, they participate in international scientific networks, take part in international publications prepared in the conclusion of studies and obtain the opportunity to join national / international decision-making committees.
  • According to a PubMed study which examined the trends of clinical research publications between 1995 and 2015, the 30 countries that generate the highest number of scientific content produced 94.6 % of all publications and contributed 98.1% of the main clinical journals globally. According to the same analysis Turkey, is ranked 31st with 55 publications in "systematic review" and "meta-analysis" category, while it ranks 18th with 671 publications in "clinical studies" category. Turkey is globally ranked in 17th place with 19,963 articles in all publications.
  • Data obtained from physicians participating in clinical trials are based on evidence rather than personal experience. For this reason, evidence-based data obtained when a physician participates in a clinical trial can serve as a source for other scientists who will later participate in the study. With increasing familiarity with rare diseases and specific cases, scientists can rely on more evidence based data and more reliable experience in their future treatment decisions.

The report recommends 12 steps in several areas to increase the number of clinical trials in Turkey

  • Creating a central patient database
  • Designing a patient referral system
  • Raising public awareness
  • Facilitating documentation and ethics committee application, centralization
  • Ensuring the implementation of ethical review standards
  • Creating a researchers network
  • Increasing capacity in a wider range of institutions
  • Offering formal education, academic incentives and career development opportunities
  • Reviewing R&D regulations
  • Establishing clinical research centers with dedicated staff
  • Improving accounting systems in healthcare institutions
  • Increasing incentives for companies to conduct clinical trials in Turkey

After the launch, it is planned to hold under the leadership of TITCK and TUSEB a series of workshops with the participation of relevant parties in the clinical studies ecosystem, and to prepare an action plan to implement the recommendations in the report.